Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035710892

FEI Number

3035710892

Entity Name

Guangdong MacroLux Medical Technology Co., Ltd.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

501, Building 6, No.4, Xinxi Road, Songshan Lake High-Tech Industrial Development Zone, Dongguan Guangdong 523787, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

MacroLux Medical Technology Co., Ltd. (Owner Number: 10089857)

Owner / Operator Contact Address

301, Building 3, NamTai Inno Park In Guang Ming Avenue, Guangming, Shenzhen, CN-GD 518107, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

BubbleView Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR) ViewHub® Video Processor (S13, S13-T, S13-N, S13-S) Trolley SeleneView® Single-Use Digital Hysteroscope (HC29, HC29-G, HC35, HC35-G, HO35, HO35-G, HO42, HO42-G) ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-06-12
FOX	Stand, Infusion	General Hospital	Class 1	880.6990	2025-08-26
HIH	Hysteroscope (And Accessories)	Obstetrics/Gynecology	Class 2	884.1690	2024-08-20

Official Correspondent

Linbin Ye

US Agent Details

Sarah Galemmo Business: ICAS Biologics Co., Ltd. Email: US.agent@icas.org.cn Phone: (661) 8033155

Related Public Records

Same Entity

MacroLux Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3029929134	MACROLUX MEDICAL TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K935716	KARL STORZ Endoscopy-America, Inc.	KARL STORZ FIXED MAGNIFICATION TELESCOPE/KS VARIABLE MAGNIFICATION TELESCOPE	1995-11-16

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9614434	STORZ ENDOSKOP PRODUKTIONS GMBH	SCHAFFHAUSEN, CH
3008386005	IAN JAMIESON PTY LTD	Fyshwick Australian Capital Territory, AU
3008837339	STRYKER EMEA Supply Chain Services	Venlo Limburg, NL
3007127244	TAIWAN ADVANCED STERILIZATION TECHNOLOGY INC.	Taichung County, TW

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035710892. Last updated year: 2026. Please use registration number 3035710892 when referencing this establishment in official correspondence.